STRONG DENTAL HANDPIECES

K100192 · Saeshin Precision Co., Ltd. · EGS · Feb 4, 2010 · Dental

Device Facts

• Record ID: K100192
• Device Name: STRONG DENTAL HANDPIECES
• Applicant: Saeshin Precision Co., Ltd.
• Product Code: EGS · Dental
• Decision Date: Feb 4, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The STRONG Dental Handpieces is indicated for wide range of dental procedures. AT- II for the application in the area of the front teeth, root tip resection, bone removal, osteotomia on the upper and lower jaw, preprosthetic surgical modellation, sequestrotomia, fenestration on the alveolar appendix, apical ventilation, bone modellation, bone smoothing. ACL-01, ACL(B)-01C and ACL-02C for the osteotomia on the upper and lower jaw, germectomia, sequestrotomia.

Device Story

STRONG Dental Handpieces (models AT-II, ACL-01C, ACL(B)-01C, ACL-02C) are mechanical dental instruments; 1:1 transmission ratio; attach to torque-adjustable electrical motors via ISO 3964 coupling; accept ISO 1797-1 compliant instruments. Used by dental professionals for surgical procedures including bone removal, osteotomia, and root tip resection. Device provides mechanical rotation for cutting/shaping bone or teeth; facilitates surgical access in difficult-to-reach areas. Benefits include precise bone/tooth modification during oral surgery.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and intended use comparison to predicate devices.

Technological Characteristics

Mechanical dental handpiece; 1:1 transmission ratio; ISO 3964 coupling; ISO 1797-1 instrument shank compatibility; manual operation via external electrical motor.

Indications for Use

Indicated for dental procedures including root tip resection, bone removal, osteotomia, preprosthetic surgical modellation, sequestrotomia, fenestration, apical ventilation, bone smoothing, and germectomia.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• Surgical Contra-Angle Handpieces Types WS-56E, Surgical straight Handpieces Types, S-11 (K011061)
• STRONG Implant Handpieces (K092412)

Submission Summary (Full Text)

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K100192

019

.

Image /page/0/Picture/2 description: The image shows the logo for SAESHIN. The logo consists of a stylized letter "S" inside of a circle on the left, followed by the word "SAESHIN" in a bold, sans-serif font. The logo is black and white.

Saeshin Precision Co., Ltd.

#93-15, Paho-Dong, Dalseo-Gu, Daegu, 704-220, Republic of Korea Tel [phone] Fax [phone]

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

Date: November 30, 2009

1. Company and Correspondent making the submission:

| | Company |
|-------------------------|---------------------------------------------------------------------|
| Name | Saeshin Precision Co., Ltd. |
| Address | #93-15, Paho-dong, Dalseo-Gu, Daegu, 704-<br>220, Republic of Korea |
| Phone<br>Fax<br>Contact | [phone]<br>[phone]<br>Y. S. Lee |

- 2. Device:
Proprietary Name - STRONG Dental Handpieces Common Name - Dental Handpieces and Accessories Classification Name - Handpiece, Contra- And Right-Angle Attachment, Dental

- 3. Predicate Device:
- · Surgical Contra-Angle Handpieces Types WS-56E, Surgical straight Handpieces Types, S-11, K011061
- · STRONG Implant Handpieces, K092412
- 4. Classifications Names & Citations: EGS, 872.4200
- 5. Description:

The STRONG Dental Handpieces; AT-II, ACL-01C, ACL(B)-01C and ACL-02C is The STRONG Dental handpieces with transmission ratio of 1:1. It can be driven by torque adjustable electrical motors for surgery treatment. It is attached to drive via ISO 3964 coupline. The head clamp accepts instrument complying with ISO 1797-1. It has contra-angle(AT-II has straight-angle) attachment for difficult to reach 1797-1. It has contra digities for restorations, such as fillings, and for cleaning teeth.

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Image /page/1/Picture/0 description: The image shows the logo for Saeshin. The logo consists of a stylized letter "S" inside of a circle on the left, followed by the word "SAESHIN" in bold, sans-serif font. The logo is black and white.

Saeshin Precision Co., Ltd.

#93-15, Paho-Dong, Dalseo-Gu, Daegu, 704-220, Republic of Korea Tel [phone] Fax [phone]

- Indication for use: 6.
The STRONG Dental Handpieces is indicated for wide range of dental procedures.

- AT- II for the application in the area of the front teeth, root tip resection, bone . removal, osteotomia on the upper and lower jaw, preprosthetic surgical modellation, sequestrotomia, fenestration on the alveolar appendix, apical ventilation, bone modellation, bone smoothing.
- ACL-01, ACL(B)-01C and ACL-02C for the osteotomia on the upper and lower . jaw, germectomia, sequestrotomia.

## 7. Review:

The STRONG Dental Handpieces has the same device characteristics as the predicate The Surgical Contra-Angle handpieces Types WS-56E, Surgical Straight Handpieces Types S-11; intended use, material, design and use concept are similar. And they also comply to ISO 3964 coupling and ISO 1797-1 shank.

Based on the comparison of intended use and technical features, the STRONG Dental Handpieces are substantially equivalent to the predicate devices.

- 8. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Saeshin Precision Co., Ltd. concludes that the STRONG Dental Handpieces is safe and effective and substantially equivalent to predicate devices as described herein.

- 9. Saeshin Precision Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Saeshin Precision Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated Laboratory and Testing 2600 Northwest Lake Road Camas, Washington 98607-9526

Re: K100192

Trade/Device Name: STRONG Dental Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Acessories Regulatory Class: I Product Code: EGS Dated: January 4, 2010 Received: January 22, 2010

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

FEB - 4 2010

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## Page 2 - Mr. Mouser

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K K106192

Device Name: STRONG Dental Handpieces

Indication for use:

The STRONG Dental Handpieces is indicated for wide range of dental procedures.

- AT II for the application in the area of the front teeth, root tip resection, bone . removal, osteotomia on the upper and lower jaw, preprosthetic surgical modellation, sequestrotomia, fenestration on the alveolar appendix, apical ventilation, bone modellation, bone smoothing.
- ACL-01, ACL(B)-01C and ACL-02C for the osteotomia on the upper and lower ● jaw, germectomia, sequestrotomia.

Prescription Use (Per 21CFR801 Subpart D)

Over-The-Counter Use -(Per 21CFR801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation

R.Shetz, DNS for Dr. K.P. muley
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Uental Devices

510(k) Number: K/00192

SAESHIN PRECISION Co., Ltd.